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Lonza Supplies Portola’s Second-Gen Andexxa

FDA's green light of Portola's Prior Approval Supplement (PAS) for second-gen Andexxa follows tie-up with Lonza to develop the manufacturing process

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Following the recent U.S Food and Drug Administration (FDA) approval of the Prior Approval Supplement (PAS) for second-generation Andexxa, Portola Pharmaceuticals and Lonza started commercial supply of the recombinant coagulation factor from Lonza’s Porriño, Spain facility.
 
The production at Lonza Pharma & Biotech’s 10,000L mammalian facility in Porriño will be supplemented by additional large-scale capacity in Ibex Dedicate at Lonza’s Visp, Switzerland site when it comes on line in 2020. The two sites will ensure the flexible supply of Andexxa to patients.
 
Lonza worked closely with Portola to develop the second-generation manufacturing process for Andexxa.
 
“Our teams have taken up the challenge with Portola by combining our expertise to ensure their product can reach the patients who need it,” said Sylke Hassel, head of commercial mammalian and microbial manufacturing, Lonza Pharma & Biotech.

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